Apparatus and method of placement of a graft or graft system

ABSTRACT

An endoluminal prosthesis system deployable in a region of a patient&#39;s vasculature having one or more branch vessels, having a main graft body having a first opening in a wall portion of the main graft body and a pre-loaded guidewire positioned inside the main graft body and advanced through the first opening. One or more branch grafts can be attached to the main graft body to cover one or more openings in the main graft body.

PRIORITY CLAIM AND INCORPORATION BY REFERENCE

This application is a continuation of U.S. patent application Ser. No.14/840,428, filed Aug. 31, 2015, (entitled “APPARATUS AND METHOD OFPLACEMENT OF A GRAFT OR GRAFT SYSTEM”), which is a continuation of U.S.patent application Ser. No. 14/172,126, now U.S. Pat. No. 9,148,381,filed Feb. 4, 2014, (entitled “APPARATUS AND METHOD OF PLACEMENT OF AGRAFT OR GRAFT SYSTEM”), which is a continuation of U.S. patentapplication Ser. No. 13/546,950, now U.S. Pat. No. 8,672,989, filed onJul. 11, 2012 (entitled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT ORGRAFT SYSTEM”), which is a continuation of U.S. patent application Ser.No. 12/390,346, now U.S. Pat. No. 8,221,494, filed on Feb. 20, 2009(entitled “APPARATUS AND METHOD OF PLACEMENT OF A GRAFT OR GRAFTSYSTEM”), which claims the benefit under 35 U.S.C. § 119 of U.S.Provisional Patent Application No. 61/030,913, filed Feb. 22, 2008(entitled “METHOD of PLACEMENT OF AN AORTIC GRAFT”), all of which arehereby incorporated by reference in their entirety as if fully set forthherein.

BACKGROUND Technical Field

The present invention relates to endoluminal vascular prostheses andmethods of placing such prostheses, and, in one application, toendoluminal vascular prostheses for use in the treatment of vessels withbranches.

Description of the Related Art

An abdominal aortic aneurysm is a sac caused by an abnormal dilation ofthe wall of the aorta, a major artery of the body, as it passes throughthe abdomen. The abdomen is that portion of the body which lies betweenthe thorax and the pelvis. It contains a cavity, known as the abdominalcavity, separated by the diaphragm from the thoracic cavity and linedwith a serous membrane, the peritoneum. The aorta is the main trunk, orartery, from which the systemic arterial system proceeds. It arises fromthe left ventricle of the heart, passes upward, bends over and passesdown through the thorax and through the abdomen to about the level ofthe fourth lumbar vertebra, where it divides into the two common iliacarteries.

The aneurysm usually arises in the infrarenal portion of the diseasedaorta, for example, below the kidneys. When left untreated, the aneurysmmay eventually cause rupture of the sac with ensuing fatal hemorrhagingin a very short time. High mortality associated with the rupture leadinitially to transabdominal surgical repair of abdominal aorticaneurysms. Surgery involving the abdominal wall, however, is a majorundertaking with associated high risks. There is considerable mortalityand morbidity associated with this magnitude of surgical intervention,which in essence involves replacing the diseased and aneurysmal segmentof blood vessel with a prosthetic device which typically is a synthetictube, or graft, usually fabricated of polyester, urethane, Dacron®,Teflon®, or other suitable material.

To perform the surgical procedure requires exposure of the aorta throughan abdominal incision which can extend from the rib case to the pubis.The aorta must typically be closed both above and below the aneurysm, sothat the aneurysm can then be opened and the thrombus, or blood clot,and arteriosclerotic debris removed. Small arterial branches from theback wall of the aorta are tied off. The Dacron® tube, or graft, ofapproximately the same size of the normal aorta is sutured in place,thereby replacing the aneurysm. Blood flow is then reestablished throughthe graft. It is necessary to move the intestines in order to get to theback wall of the abdomen prior to clamping off the aorta.

If the surgery is performed prior to rupturing the abdominal aorticaneurysm, the survival rate of treated patients is markedly higher thanif the surgery is performed after the aneurysm ruptures, although themortality rate is still quite high. If the surgery is performed prior tothe aneurysm rupturing, the mortality rate of typically slightly lessthan 10%. Conventional surgery performed after the rupture of theaneurysm is significantly higher, one study reporting a mortality rateof 66.5%. Although abdominal aortic aneurysms can be detected fromroutine examinations, the patient does not experience any pain from thecondition. Thus, if the patient is not receiving routine examinations,it is possible that the aneurysm will progress to the rupture stage,wherein the mortality rates are significantly higher.

Disadvantages associated with the conventional, prior art surgery, inaddition to the high mortality rate included the extended recoveryperiod associated with such surgery; difficulties in suturing the graft,or tube, to the aorta; the loss of the existing aorta wall andthrombosis to support and reinforce the graft; the unsuitability of thesurgery for many patients having abdominal aortic aneurysms; and theproblems associated with performing the surgery on an emergency basisafter the aneurysm has ruptured. A patient can expect to spend from oneto two weeks in the hospital after the surgery, a major portion of whichis spent in the intensive care unit, and a convalescence period at homefrom two to three months, particularly if the patient has otherillnesses such as heart, lung, liver, and/or kidney disease, in whichcase the hospital stay is also lengthened. Since the graft musttypically be secured, or sutured, to the remaining portion of the aorta,it is many times difficult to perform the suturing step because thethrombosis present on the remaining portion of the aorta, and thatremaining portion of the aorta wall may many times be friable, or easilycrumbled.

Since many patients having abdominal aortic aneurysms have other chronicillnesses, such as hart, lung, liver, and/or kidney disease, coupledwith the fact that many of these patients are older, the average agebeing approximately 67 years old, these patients are not idealcandidates for such major surgery.

More recently, a significantly less invasive clinical approach toaneurysm repair, known as endovascular grafting, has been developed.Parodi, et al. provide one of the first clinical descriptions of thistherapy. Parodi, J. C., et al., “Transfemoral Intraluminal GraftImplantation for Abdominal Aortic Aneurysms,” 5 Annals of VascularSurgery 491 (1991). Endovascular grafting involves the transluminalplacement of a prosthetic arterial graft in the endoluminal position(within the lumen of the artery). By this method, the graft is attachedto the internal surface of an arterial wall by means of attachmentdevices (expandable stents), typically one above the aneurysm and asecond stent below the aneurysm.

Stents can permit fixation of a graft to the internal surface of anarterial wall without sewing or an open surgical procedure. Expansion ofradially expandable stents is conventionally accomplished by dilating aballoon at the distal end of a balloon catheter. In U.S. Pat. No.4,776,337, for example, Palmaz described a balloon-expandable stent forendovascular treatments. Also known are self-expanding stents, such asdescribed in U.S. Pat. No. 4,655,771 to Wallsten.

In certain conditions, the diseased region of the blood vessels extendsacross branch vessels. The blood flow into these branch vessels iscritical for the perfusion of the peripheral regions of the body andvital organs. Many arteries branch off the aorta. For example, thecarotid arteries supply blood into the brain, the renal arteries supplyblood into the kidneys, the superior mesenteric artery (“SMA”) suppliesthe pancreas, and hypogastric arteries to the reproductive organs, andthe subclavian arteries supply blood to the arms. When the aorta isdiseased, the branch vessels may also be affected. Thoracic aorticaneurysms may involve the subclavian and carotid arteries, abdominalaneurysm may involve the SMA, renal and hypogastric arteries. Aorticdissections may involve all branch vessels mentioned above.

There is a need to place endoluminal prostheses in the aorta withoutobstructing critical branch vessels. The embodiments of the endoluminalprostheses disclosed herein provide a solution to the problems describedabove.

SUMMARY OF SOME EXEMPLIFYING EMBODIMENTS

Some embodiments of the endoluminal prosthesis disclosed herein pertainto the design and method of placement of a branch graft system forendovascular treatment of diseased blood vessels. The branch graftsystem can comprise a tubular expandable main body and at least onebranch graft. The branch graft is made from an expandable material,which can be ePTFE. In some embodiments, the diameter of the branchgraft can be sufficiently small to be manipulated into the desiredvascular position by moving the branch graft over the guidewire. Thebranch graft can be expanded to the diameter of the branch vessel bymechanical means, which can be a dilation balloon. In another embodimentof an endoluminal prosthesis, the main body of the branch graft systemcan have one large opening in the wall of the graft for the treatment ofa second branch vessel. A second branch graft system can be placedinside the first branch graft system, wherein the branch graft of thesecond branch graft system passed through the opening of the firstbranch graft system and the large opening of the second branch graftsystem overlaps with the branch graft of the first branch graft system.

In some embodiments, an endoluminal prosthesis system is disclosed thatcan comprise a first endoluminal prosthesis comprising a first maingraft body having at least a first and a second opening therein and asecond endoluminal prosthesis comprising a second main graft body havingat least a first and a second opening therein. The first opening in thefirst main graft body can be smaller than the second opening in thefirst main graft body, and the first opening in the second main graftbody can be smaller than the second opening in the second main graftbody. Further, the second main graft body can be configured to beexpandable substantially within the first main graft body such that thesecond opening of the second main graft body does not cover any portionof the first opening in the first main graft body, and such that thesecond opening of the first main graft body does not cover any portionof the first opening in the second main graft body. In some embodiments,when the second main graft body has been expanded within the first maingraft body, the resulting endoluminal prosthesis system can have twosmall openings therein that are each approximately equivalent indiameter to the first opening in each of the first and second main graftbodies.

In some embodiments, a method of deploying a branch graft system in aportion of a patient's blood vessel having at least a first and a secondbranch blood vessel is described. In some embodiments, the method cancomprise positioning a first main graft body having at least a first anda second opening therein in the patient's blood vessel and so that thefirst opening can be substantially aligned with the first branch bloodvessel and so that the second opening can be sufficiently aligned withthe second branch blood vessel so that the first main graft body doesnot substantially cover either the first or second branch blood vessel.The method can further comprise positioning at least a portion of asecond main graft body having at least a first and a second openingtherein within the inside of the first main graft body so that the firstopening of the second main graft body can be substantially aligned withthe second branch blood vessel and so that the second opening of thesecond main graft body can be sufficiently aligned with the first branchblood vessel so that the second main graft body does not substantiallycover either the first or second branch blood vessel. The method canfurther comprise expanding the first and second main graft bodiesagainst the patient's blood vessel to create a multi-layer graft systemhaving two openings through the wall thereof that are substantiallyaligned with the first and second blood vessels and have a diametersubstantially equal to the first opening of each of the first and secondmain graft bodies, and supporting the first and second main graft bodiesagainst the patient's blood vessel. In some embodiments the secondopening in each of the first and second main graft bodies can besubstantially larger than the first opening in each of the first andsecond main graft bodies.

In some embodiments, an endoluminal prosthesis is disclosed that cancomprise an expandable main graft portion having an axial openingtherethrough and at least a first branch opening therein and anexpandable branch graft portion having a proximal end portion, a distalend portion, and an axial opening therethrough. In some embodiments, thebranch graft portion can be supported by the main graft portion and thebranch graft portion can be supported by the main graft portion so thatthe proximal end portion of the branch graft portion can be positionedaround a periphery of the first branch opening in the main graft, andsuch that the axial opening through the branch graft portion can be incommunication with the first branch opening formed in the main graftportion. In some embodiments, at least the distal end portion of thebranch graft portion can be in a first, unexpanded state. In otherwords, in some embodiments, before the branch graft has been deployed inthe desired vascular location, the distal end portion of the branchgraft portion can have a diameter that is less than the diameter of theproximal end portion of the branch graft portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an embodiment of an endoluminalprosthesis.

FIG. 1B is a perspective view of the main graft body of the embodimentof the endoluminal prosthesis illustrated in FIG. 1A.

FIG. 1C is a perspective view of the partially expanded branch graft ofthe embodiment of the endoluminal prosthesis illustrated in FIG. 1A.

FIG. 1D is a perspective view of the branch graft illustrated in FIG. 1Bbefore the branch graft 14 has been partially expanded.

FIG. 1E is a partial section of the branch graft illustrated in FIG. 1D,wherein a portion of the branch graft has been partially expanded withthe use of the balloon expander.

FIG. 2 is a partial section view of a portion of the embodiment of theendoluminal prosthesis illustrated in FIG. 1A, after the branch graftportion of the endoluminal prosthesis has been positioned within abranch artery.

FIG. 3 is a partial section view of a portion of the embodiment of theendoluminal prosthesis illustrated in FIG. 1A, showing a balloonexpandable stent being positioned within the partially expanded branchgraft of the endoluminal prosthesis.

FIG. 4 is a partial section view of a portion of the embodiment of theendoluminal prosthesis illustrated in FIG. 1A, showing a balloonexpandable stent being expanded within the branch graft of theendoluminal prosthesis.

FIG. 5 is a partial section view of a portion of the embodiment of theendoluminal prosthesis illustrated in FIG. 1A, showing an expanded stentpositioned within a branch graft of the endoluminal prosthesis.

FIG. 6 is a graphical illustration of the location of the two renalarteries with respect to the superior mesenteric artery (“SMA”) in 50patients undergoing an abdominal aortic aneurysm (“AAA”) procedure.

FIGS. 7A and 7B are a front view and a section view, respectively, ofanother embodiment of an endoluminal prosthesis.

FIGS. 8A, 8B, and 8C are a perspective view, top view, and section view,respectively, of yet another embodiment of an endoluminal prosthesis.

FIGS. 9A and 9B are a perspective view and a side view, respectively, ofan embodiment of a fenestrated endoluminal prosthesis.

FIGS. 10A and 10B are a perspective view and a side view, respectively,of another embodiment of a fenestrated endoluminal prosthesis.

FIGS. 11A and 11B are a perspective view and a side view, respectively,of another embodiment of a fenestrated endoluminal prosthesis.

FIG. 12 is a partial section view of the endoluminal prosthesisillustrated in FIGS. 10A, 10B positioned within an embodiment of adelivery catheter.

FIG. 13 is a side view of the embodiment of the endoluminal prosthesisillustrated in FIGS. 10A, 10B before the endoluminal prosthesis isplaced in a delivery catheter.

FIG. 14 is a partial section view of a patient's vasculatureillustrating guidewires inserted through the abdominal aortic and intothe renal arteries.

FIG. 15 is a perspective view of the embodiment of the endoluminalprosthesis illustrated in FIGS. 10A, 10B in the deployed or expandedstate.

FIG. 16 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis illustrated in FIGS. 10A, 10Bdeployed in the desired position within the patient's vasculature, afterthe components of the delivery system except for the guidewires havebeen retracted from the patient's vasculature.

FIG. 17 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis illustrated in FIGS. 10A, 10Bdeployed in the desired position within the patient's vasculature, afterall of the components of the delivery system have been retracted fromthe patient's vasculature.

FIG. 18 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis illustrated in FIGS. 11A, 11Balso deployed in the desired position within the patient's vasculature,after the components of the delivery system except for the guidewireshave been retracted from the patient's vasculature.

FIG. 19 is a partial section view of a patient's vasculatureillustrating both endoluminal prostheses positioned in the desiredposition within the patient's vasculature, after the components of thedelivery system have been retracted from the patient's vasculature.

FIG. 20 is a perspective view of another embodiment of an endoluminalprosthesis with a scalloped end portion.

FIG. 21 is a perspective view of another embodiment of an endoluminalprosthesis with a large opening open to the proximal end of the graft.

FIG. 22 is a partial section view of a patient's vasculatureillustrating two of the endoluminal prostheses illustrated in FIG. 21deployed in the desired position within the patient's vasculature, afterthe components of the delivery system except for the hollow guidewireshave been retracted from the patient's vasculature.

FIGS. 23 and 24 are partial section views of a patient's vasculatureillustrating two of the endoluminal prostheses illustrated in FIG. 21deployed in the desired position within the patient's vasculature,further illustrated a branch graft deployment catheter being guided intothe right renal artery over a guidewire.

FIG. 25 is a partial section view of a patient's vasculatureillustrating an embodiment of a stent being deployed in the branch graftpositioned in a patient's right renal artery.

FIG. 26 is a partial section view of a patient's vasculatureillustrating an embodiment of a stent after it has been deployed in thebranch graft positioned in a patient's right renal artery.

FIG. 27 is a partial section view of a patient's vasculatureillustrating an embodiment of a stent after it has been deployed in thebranch graft positioned in a patient's right renal artery, furtherillustrating the delivery catheter being removed from the patient'svasculature.

DETAILED DESCRIPTION OF SOME EXEMPLIFYING EMBODIMENTS

The following detailed description is now directed to certain specificembodiments of the disclosure. In this description, reference is made tothe drawings wherein like parts are designated with like numeralsthroughout the description and the drawings.

Certain embodiments described herein are directed to systems, methods,and apparatuses to treat lesions, aneurysms, or other defects in theaorta, including, but not limited to, the thoracic, ascending, andabdominal aorta, to name a few. However, the systems, methods, andapparatuses may have application to other vessels or areas of the body,or to other fields, and such additional applications are intended toform a part of this disclosure. For example, it will be appreciated thatthe systems, methods, and apparatuses may have application to thetreatment of blood vessels in animals. In short, the embodiments and/oraspects of the endoluminal prosthesis systems, methods, and apparatusesdescribed herein can be applied to other parts of the body or may haveother applications apart from the treatment of the thoracic, ascending,and abdominal aorta. And, while specific embodiments may be describedherein with regard to particular portions of the aorta, it is to beunderstood that the embodiments described can be adapted for use inother portions of the aorta or other portions of the body and are notlimited to the aortic portions described.

FIG. 1A is a perspective view of an embodiment of an endoluminalprosthesis 10 (also sometimes referred to herein as a branch graftsystem) having a main body graft 12 and at least one branch graft 14.The branch graft 14 is shown in a partially expanded state. In someconfigurations, the main body graft 12 can be positioned in theabdominal aorta, which the branch graft or grafts 14 can be positionedwithin the left or right renal artery. In some configurations, thebranch graft or grafts 14 can be positioned within any one orcombination of the following: left renal artery, right renal artery,second lumbar, testicular, inferior mesenteric, middle sacral, or othervessels branching from the aorta. Thus, in some embodiments, theendoluminal prosthesis 10 can comprise any number of branch grafts 14that are required for the specific application, including, but notlimited to, two, three, or more branch grafts 14.

Because the branch graft or grafts 14 can be configured to confirm to awide range of vessels and a wide range of positions, the branch graft orgrafts 14 can be of any suitable size, shape, or configuration, and canbe attached to the main body graft 12 in any of a wide variety oflocations. Therefore, some embodiments of the endoluminal prosthesis 10can comprise only one branch graft 14. However, in some embodiments, theendoluminal prosthesis 10 can comprise two or more branch grafts 14, orany suitable number depending on the application.

FIG. 1B is a perspective view of the main body graft 12 of theembodiment of the endoluminal prosthesis 10 illustrated in FIG. 1A. FIG.1C is a perspective view of the partially expanded branch graft 14 ofthe embodiment of the endoluminal prosthesis 10 illustrated in FIG. 1A.FIG. 1C illustrates the branch graft 14 before it has been assembledwith the main body graft 12 to form the embodiment of the endoluminalprosthesis 10 illustrated in FIG. 1A. FIG. 1D is a perspective view ofthe branch graft 14 illustrated in FIG. 1B before the branch graft 14has been partially expanded. FIG. 1E is a partial section view of thebranch graft illustrated in FIG. 1D, wherein a portion of the branchgraft 14 has been partially expanded with the use of the balloonexpander 16.

With reference to FIGS. 1A-1E, one of the many suitable methods forfabricating some embodiments of the endoluminal prosthesis 10 will bedescribed. As will be described, the branch graft 14 in the pre-expandedstate as shown in FIG. 1D can be partially expanded by the balloonexpander 16 to form the partially expanded branch graft 14 shown inFIGS. 1A, 1C. In some embodiments, only the proximal end portion 14 a ofthe branch graft 14 (i.e., the end of the branch graft 14 closest toopening 14 b) can preferably be expanded by the balloon expander 16. Toexpand the branch graft 14, the balloon expander 16 can be partiallyinserted into the proximal end portion 14 a of the pre-expanded branchgraft 14 (shown in FIG. 1D) and inflated until the proximal end portion14 a of the branch graft 14 reaches the desired or suitable size. Whilethe expansion being of the branch graft 14 can be performed with aballoon expander 16, as is illustrated in FIG. 1E, any suitable methodof expanding the branch graft 14 can be employed, including but withoutlimitation other forms of mechanical expanders. Thus, FIG. 1Eillustrated only one of several suitable methods for partially expandingthe pre-expanded branch graft 14 illustrated in FIG. 1D to form thepartially expanded branch graft 14 illustrated in FIG. 1A, 1C.

In some arrangements, the proximal end portion 14 a of the branch graft14 can be expanded to approximately match or confirm to the expecteddiameter of the branch vessel and/or the diameter of the opening 12 a.Thus, the branch graft 14 can be configured so as to be expandable overa wide range of sizes and cross-sectional shapes, depending on the sizeor shape of the branch vessel that the branch graft 14 is intended to besupported by. After removing the balloon expander 16, the proximalportion of the partially expanded branch graft 14 can be trimmed toconform to the opening 12 a formed in the main body graft 12. Theopening 12 a can be sized and positioned to confirm to the desired sizelocation of the partially expanded branch graft 14. Thereafter, asmentioned, the branch graft 14 can be attached to the main body graft 12using adhesive, sutures, or any other suitable attachment method, toform the endoluminal prosthesis 10 illustrated in FIG. 10A. Any portionof the endoluminal prosthesis 10, including the main body graft 12and/or the branch graft 14, or any other endoluminal prosthesisdisclosed herein can be formed from PTFE, ePTFE, polyester, urethane,Dacron, Dacron®, Teflon®, or any other distensible polymeric material orother suitable material.

In some embodiments, the sutures used to attach the branch graft 14 (orany other branch graft disclosed herein) to the main body 12 (or anyother main body or graft portion disclosed herein) can be made from aradiopaque (“RO”) material so that the location of the branch graft canbe perceived in an x-ray or other radiation transition duringdeployment. In some embodiments, the sutures an be made from platinum,gold, barium sulfate, or any other suitable RO material. Alternatively,RO markers can be sewn to or otherwise attached to the main body of theendoluminal prosthesis at any suitable position, such as but not limitedto adjacent to or on the branch graft or near the end portions of themain body, again to aid in visualization of the endoluminal prosthesisduring deployment.

In some embodiments, the diameter of the pre-expanded branch graft 14(shown in FIG. 1D) can be from approximately 1 mm or less toapproximately 3 mm or more. However, the pre-expanded diameter of thepre-expanded branch graft 14 (as illustrated in FIG. 1D) can be anysuitable cross-sectional size or shape depending on the size and shapeof the target artery or blood vessels. Additionally, in someembodiments, the shape of the pre-expanded branch graft 14 can becylindrical. However, the shape of the pre-expanded branch graft 14 isnot so limited. The pre-expanded branch graft 14 can define a curved,angled, tapered or other suitable shape.

In some embodiments, the branch graft 14 can be integrally formed withthe main body graft 12. In some embodiments, the branch graft 14 can beattached to the main body graft 12 using sutures, adhesive, or any othersuitable attachment material or method. The junction between the branchgraft or grafts 14 and the main body graft 12 can be sealed so as tosubstantially inhibit or prevent blood from leaking through the junctionand flowing between the main body graft 12 and the aorta or other bloodvessel that the main body graft 12 is positioned within. In someembodiments, the junction between the branch graft or grafts 14 and themain body graft 12 can be sealed so as to inhibit or prevent at leastthe majority of the blood flowing therethrough from leaking through thejunction and flowing between the main body graft 12 and the aorta orother blood vessel that the main body graft 12 is positioned within. Inthis configuration, the endoluminal prosthesis 10 can be lesssusceptible to leakage between the main body graft 12 and the aorta orblood vessel at the blood vessel branch point as compared toconventional fenestrated graft systems.

In some embodiments, the main body graft 12 or the branch graft 14 ofthe endoluminal prosthesis 10 can be similar in size, material, or otherdetails to other suitable expandable bifurcated or non-bifurcatedendoluminal prostheses presently known or later developed in the art, orcan be of any size, material, or other details of any other prosthesispresently known or later developed in the art. For example, withoutlimitation, in some embodiments, the main body graft 12 or the branchgraft 14 can comprise any of the materials, features, or other aspectsof the embodiments of the polymeric sleeves or the tubular wire supportsdisclosed in U.S. Pat. No. 6,077,296 (titled ENDOLUMINAL VASCULARPROSTHESIS and filed on Mar. 4, 1998), U.S. Pat. No. 6,187,036 (titledENDOLUMINAL VASCULAR PROSTHESIS and filed on Dec. 11, 1998), U.S. Pat.No. 6,197,049 (titled ARTICULATING BIFURCATION GRAFT and filed on Feb.17, 1999), U.S. Pat. No. 6,500,202 (titled BIFURCATION GRAFT DEPLOYMENTCATHETER and filed on Mar. 15, 2000), U.S. Pat. No. 6,660,030 (titledBIRFURCATION GRAFT DEPLOYMENT CATHETER and filed on Dec. 22, 2000), orU.S. Pat. No. 6,733,523 (titled IMPLANTABLE VASCULAR GRAFT and filed onJun. 26, 2001). The entirety of each of the above-listed patents arehereby incorporated by reference as if fully set forth herein.

For example, in some embodiments, the main body graft 12 and/or thebranch graft 14 can be expanded using an uncovered (i.e., bare)self-expanding metal frame or a self-expanding metal frame covered witha thin graft material, which can be made form ePTFE, as disclosed inU.S. Pat. No. 6,077,296. However, the specific design and selection ofthe materials, shapes, or other aspects for the main body graft 12 orthe branch graft 14 of the endoluminal prosthesis 10 is not limited tothe designs and configurations disclosed or incorporated by referenceherein, but can be based on any suitable variety of materials, shapes,or other aspects of any other suitable endoluminal prostheses.Additionally, the main body graft 12 and/or the branch graft 14 (or anyother main or branch graft disclosed herein) can be expanded using amechanical expander, and be held in the expanded position against theblood vessel wall by the blood pressure within the vessel (i.e., withoutthe use of a stent).

In some embodiments, the main body graft 12 can comprise an expandablemetal frame to support the main body graft 12 within the aorta (notillustrated). The frame supporting the main body graft 12 of theendoluminal prosthesis 10 can be formed from a metal or any othersuitable material, can be configured so as to not obstruct the flow ofblood through the opening 14 b in the branch graft or grafts 14. Themetal frame can comprise a self-expandable structure comprising one ormore wires forming a zig-zag, tubular shape, as described above withreference to U.S. Pat. Nos. 6,077,296, 6,187,036, 6,197,049, 6,500,202,6,660,030 and/or 6,733,523. In some embodiments, the metal frame can beformed by laser cutting a tubular structure. Such structures are wellknown in the art. However, those of skill in the art will recognize thatvarious configurations and constructions of the frame can be used inlight of the disclosure herein.

FIG. 2 is a partial section view of a portion of the embodiment of theendoluminal prosthesis 10 illustrated in FIG. 1A, after the branch graftportion 14 of the endoluminal prosthesis 10 has been positioned within abranch vessel artery (represented by BV in FIG. 2). FIG. 3 is a partialsection view of a portion of the embodiment of the endoluminalprosthesis 10 illustrated in FIG. 1A, showing a balloon expandable stentbeing positioned within the partially expanded branch graft 14 of theendoluminal prosthesis 10. FIG. 4 is a partial section view of a portionof the embodiment of the endoluminal prosthesis 10 illustrated in FIG.1A, showing a balloon expandable stent being expanded within the branchgraft 14 of the endoluminal prosthesis 10. FIG. 5 is a partial sectionview of a portion of the embodiment of the endoluminal prosthesis 10illustrated in FIG. 1A, showing an expanded stent positioned within abranch graft 14 of the endoluminal prosthesis 10.

With reference to FIGS. 2-5, one method of positioning and implantingthe fully assembled endoluminal prosthesis 10 in the desired aorticlocation will now be described. After advancing a guidewire 18 throughthe vasculature into the desired branch vessel BV by known or suitablemethods, the partially expanded branch graft 14 of the endoluminalprosthesis 10 can be guided over the guidewire 18 so that the main bodygraft 12 is positioned within the desired location in the aorta and thebranch graft 14 is positioned in the desired branch vessel (representedby BV in FIG. 2).

With reference to FIG. 3, once the partially expanded branch graft 14 ispositioned within the desired branch vessel BV, a balloon-expandablestent 20 can be guided over the guidewire 18 and positioned inside thepartially expanded branch graft 14. As shown in FIG. 4, the balloonexpandable stent 20 can be expanded by the expansion of a balloon 22positioned within the balloon expandable stent 20. Once the stent 20 ofthe branch graft 14 has been expanded by the balloon 22, a balloon 22can be deflated, leaving the expanded stent 20 positioned within thebranch graft 14, as illustrated in FIG. 5.

The main body graft 12 and/or branch graft 14 the can be expanded andsecured in the desired position by any other suitable method for such.Suitable expansion apparatuses and methods include, but are not limitedto, balloon catheters, dilators, and self-expanding stents or stentgrafts. Other means of securing the main body graft 12 and/or branchgraft 14 may include, without limitation, self-expanding stents, stentgrafts, sutures, and staples.

In some embodiments, the stent 29 can be a bare wire stent of anyconfiguration described above or incorporated herein by reference. Insome embodiments, the stent 20 can be a graft covered stent, also of anyconfiguration described above or incorporated herein by reference. Agraft covered stent can provide a greater degree of safety to thepatient by providing a double layer graft system that can be less proneto tearing or other damage.

In some arrangements, after the branch stent 20 and the branch graft 14have been expanded within the desired branch vessel, the main body graft12 may thereafter be expanded within the aorta. In some arrangements,the main body graft 12 can be expanded within the aorta prior toexpanding the branch stent 14 within the branch vessel BV. The main bodygraft 12 can be expanded and held in the desired position using aself-expandable stent, or can be expanded and held in position by anyother suitable stent device, such as without limitation, a balloonexpandable stent. As such, similar to the branch graft 14, the main bodygraft 12 can be expanded and held in position with a bare metal stent ora covered stent, or any of the stents described or incorporated byreference herein.

Some embodiments of the endoluminal prosthesis 10 can be implantedwithin the desired vessel in a multistep process, such that anintegrated deployment mechanism is not used for such embodiments of theendoluminal prosthesis 10. The expansion and stenting of the branchgraft 14 can be performed in a secondary procedure, after the branchgraft 14 has been positioned in the desired blood vessel.

As mentioned, in certain situations, several vessels may branch off formthe main blood vessel in the location that is desired to be stented. Inthis case, the endoluminal prosthesis 10 can be formed with multiplebranch grafts 14 formed herein or secured thereto. For example, the tworenal arteries and the superior mesenteric artery (“SMA”) generallybranch off from the aorta in close proximity to each other. Thepositions of the branch vessels generally vary form patient to patient,as shown in FIG. 6, which is a graphical illustration of the location ofthe two renal arteries with respect to the SMA in 50 patients undergoingan abdominal aortic aneurysm (AAA) procedure. For reference, the SMA islocated at the origin of the graph. The locations of the left and rightrenal arteries are expressed in terms of axial distance from the SMA inmillimeters (x-axis), and circumferential angle from the SMA (y-axis).As FIG. 6 illustrates, there is typically a large variability in thelocations of the vessels from one patient to the next.

FIG. 6 indicates that, in case of stent grafting across the renalarteries, the small and the large opening are approximately 180 degreesopposite to each other. In some embodiments, the large opening can besufficiently large to accommodate an axial distance between the renalarteries of between approximately 15 mm and approximately 20 mm, and acircumferential asymmetry of+/−20 degrees. Thus, in some embodiments,the large opening may have a diameter of approximately 20 mm.

FIGS. 7A and 7B are a front view and a section view, respectively, ofanother embodiment of an endoluminal prosthesis 30 having a main bodygraft 32 and a branch graft 34. FIGS. 8A, 8B, and 8C are a perspectiveview, top view, and section view, respectively, of another embodiment ofan endoluminal prosthesis 40 having a main body graft 42 and a branchgraft 44.

The embodiments of the endoluminal prostheses in FIGS. 7A-8B can beconfigured for application in portions of the body other than in theportions of the aorta described above. For example, some embodiments ofthe endoluminal prosthesis 30 illustrated in FIGS. 7A, 7B can beconfigured for application in a specific artery or arteries. Inparticular, without limitation, the embodiment of the endoluminalprosthesis 30 illustrated in FIGS. 7A, 8B can be configured for use inthe thoracic aorta, with the branch graft 34 configured for positioningwithin the subclavian artery. As illustrated, in FIGS. 7A, 7B, the mainbody graft 32 can define curved portion that may be suitable for curvedvessels such as that of the subclavian artery. Other aspects of theendoluminal prosthesis 30 can be the same as or similar to any of theother endoluminal prostheses disclosed herein, and the endoluminalprosthesis 30 can be deployed and secured in the desired artery by anyof the same methods as described above with respect to endoluminalprosthesis 10.

Similarly, some embodiments of the endoluminal prostheses 40 illustratedin FIGS. 8A, 8B can also be configured for application in a specificartery or arteries. For example, without limitation, the embodiments ofthe endoluminal prosthesis 40 illustrated in FIGS. 8A, 8B can beconfigured for use in the iliac artery, with the branch graft 44configured for positioning within the hypogastric artery or arteries.However, there are many locations in the body that would benefit from aplacement of a branch graft systems or endoluminal prostheses disclosedherein to ensure perfusion of branch vessels, and none of theembodiments of the endoluminal prostheses disclosed herein are confinedto any particular portion of the body. The examples described withregard to FIGS. 7A-8B merely serve as illustrations of potentialapplications of such a branch graft system. Other aspects of theendoluminal prosthesis 40 can be the same as or similar to any of theother endoluminal prostheses disclosed herein, and the endoluminalprosthesis 40 can be deployed and secured in the desired artery by oneof the same methods as described above with respect to endoluminalprosthesis 10.

The issue of variability in the anatomy has been overcome in the past byproviding custom-made fenestrated grafts in which the openings (commonlyreferred to as fenestrations) are formed in the main body graft, whichwere generally custom-made to fit vessels of the individual patient. Onedisadvantage of custom making the fenestrated grafts after examining theindividual patients vascular anatomy is that, as mentioned, thepatient's anatomy is generally required to be closely examined usingimaging scans prior to fabricating the fenestrated graft. Subsequently,image analysis is typically required to be performed to determine thegeometrical relationship between the particular patient's main vesseland the branch vessels. This generally required the medical practitionerto individually build or modify the endoluminal prosthesis to createfenestrations at the appropriate location of the branch vessels. Thecustom-made graft then is generally required to be placed exactly in thecorrection location in the blood vessel to ensure that the fenestrationsare properly aligned with the branch vessel. Another disadvantage isthat this can be a multi-step, time consuming procedure. It is notuncommon to require several months to prepared a custom-made graft forthe patient. Additionally, the deployment of a custom-made endoluminalprosthesis can be very difficult, typically requiring a high skill levelin endovascular procedures.

The following embodiment present additional alternatives to thecustom-made fenestrated grafts discussed above. FIGS. 9A and 9B are aperspective view and a side view, respectively, of an embodiment of afenestrated endoluminal prosthesis or graft 50. As illustrated in FIGS.9A, 9B, the fenestrated graft 50 can have two openings or fenestrations52 a, 52 b formed in the main graft 50. Any of a wide ranging variety offenestrated grafts 50 can be manufactured, each having a differentlocation of the two openings or fenestrations 52 a, 52 b formed thereinso that the doctor can select the appropriately configured fenestratedgraft 50 depending on the patient's particular vasculature.

FIGS. 10A and 10B are a perspective view and a side view, respectively,of an embodiment of a fenestrated endoluminal prosthesis 60 (alsoreferred to herein as a first endoluminal prosthesis or graft), whichpresent an alternative to the custom-made fenestrated grafts discussedabove. To facilitate and description of some of the embodimentsdisclosed herein, the placement of the fenestrated endoluminalprosthesis 60 at the renal arteries is described. However, theembodiments of the fenestrated endoluminal prosthesis 60 disclosedherein are not limited to this particular location or application. Thisapplication merely serves as an example to illustrate the basic aspectsof the fenestrated endoluminal prosthesis 60.

In some embodiments, the endoluminal prosthesis 60 can comprise a mainbody 62 and first and second openings 64, 66, respectively. The mainbody 62 can have an inside surface 62 a and an outside surface 62 b. Insome embodiments, the endoluminal prosthesis 60 can comprise anysuitable or desired number of openings. For example, without limitation,the endoluminal prosthesis 60 can have one or more openings or cutouts(not illustrated) in addition to the openings 64, 66 illustrated inFIGS. 10A, 10B to account for other renal or branch arteries that mayotherwise by covered by the main body 62 of the endoluminal prosthesis60.

In the embodiment of the endoluminal prosthesis 60 illustrated in FIGS.10A, 10B, the openings 64, 66 can be positioned at mutually ordiametrically opposing locations. However, the openings 64, 66 can bepositioned at any desired or suitable axial or radial position.Additionally, in the embodiment of the endoluminal prosthesis 60illustrated in FIGS. 10A, 10B, the openings 64, 66 can have a circularshape. However, the openings 64, 66 can have any desired or suitableshape, including square, rectangular, polygonal, or otherwise.

Further, in the illustrated embodiment where each of the openings aregenerally circular, the diameter of the second opening 66 can beapproximately four times greater than the diameter of the first opening64. In some embodiments, the diameter of the second opening 66 can bebetween approximately two times greater and approximately four timesgreater, or between approximately four times greater and approximatelysix times or more greater than the diameter of the first opening 64.Additionally, in some embodiments, the second openings 66 can beconfigured to be as large as is possible to cover a wide range of branchvessel anatomies. As the size of the second opening 66 is increased, thepotential to treat a large range of branch vessel anatomies is alsoincreased.

Similarly, in some embodiments where the openings are non-circular, thewidth and/or height of the second opening 66 can be approximately fourtimes greater than the width and/or height of the first opening 64. Insome embodiments, the width and/or height of the second opening 66 canbe between approximately two times greater and approximately four timesgreater, or between approximately four times greater and approximatelysix times or more greater than the width and/or height of the firstopening 64.

In some embodiments, similar to any other prosthesis disclosed herein,the prosthesis 60 can be self-expanding, balloon expandable, or can beof any other suitable configuration. The openings 64, 66 can beconfigured to be positioned adjacent to the two renal arteries. Thefirst opening 64 can approximately match the size of the first renalartery, while the second opening 66 can be substantially larger that thefirst opening 64. As will be described in greater detail below, the sizeof the second opening 66 can be greater than the size of the firstopening 64 to account for the variability in the location of the secondrenal artery with respect to the first renal artery. In thisconfiguration, the endoluminal prosthesis 60 can be positioned withinthe patient's vasculature so that the main body 62 of the endoluminalprosthesis 60 does not cover the second renal when the first opening 64of the main body 62 is aligned with the patient's first renal artery.

As will be described in greater detail below, to seal the area aroundthe second renal artery after the first endoluminal prosthesis 60 hasbeen positioned in the patient's vasculature, another fenestratedendoluminal prosthesis 70 (also referred to herein as a secondendoluminal prosthesis or graft) comprising a main body 72, a first orsmaller opening 74, and a second or larger opening 76, can be insertedinto the patient's vasculature on the inside of the first endoluminalprosthesis 60. FIGS. 11A and 11B are a perspective view and a side view,respectively, of the embodiment of the fenestrated endoluminalprosthesis 70. The main body 72 can have an inside surface 72 a and anoutside surface 72 b.

The first or smaller opening 74 of the second endoluminal prosthesis 70can be positioned within the patient's vasculature so as to be alignedwith the patient's second renal artery. The second or larger opening 76of the second endoluminal prosthesis 70 can ensure that the first renalartery is not covered by the main body 72 of the second endoluminalprosthesis 70. The second, larger opening 66 is the first endoluminalprosthesis 60 and the second, larger opening 76 in the secondendoluminal prosthesis 70 can allow for greater variability in thelocation of the renal arteries, without requiring a medical practitionerto customer make the prosthesis.

In particular, after the first endoluminal prosthesis 60 has beenpositioned in the patient's vasculature so that the outside surface 62 bcan expand against and contact the walls of the patient's artery and sothat the first or smaller opening 64 is approximately aligned with thefirst renal artery and the second or larger opening 66 is sufficientlyaligned with the second renal artery so that the main body 62 does notcover the second renal artery, the second endoluminal prosthesis 70 canbe positioned within the patient's vasculature so that the first orsmaller opening 74 is approximately aligned with the patient's secondrenal artery and the second or larger opening 76 is sufficiently alignedwith the first renal artery so that the main body 72 does not cover thefirst renal artery. The second endoluminal prosthesis 70 can then beexpanded so that the outside surface 72 b of the main body 72 of thesecond endoluminal prosthesis 70 is in contact with the inside surface62 a of the main body 62 of the first endoluminal prosthesis 60.

In some embodiments, the second endoluminal prosthesis 70 can be thesame as or similar to the first endoluminal prosthesis 60 including, butnot limited to, having the same number, size, and location of theopenings as are in the first endoluminal prosthesis 60. In someembodiments, the second endoluminal prosthesis 70 can have a differentconfiguration as compared to the first endoluminal prosthesis 60including, but not limited to, having a different number, size, and/orlocation of the openings that are formed in the main body 72 of thesecond endoluminal prosthesis 70.

Again, the size and shape of the openings 64, 66, 74, 76 are not limitedto the illustrations or the description set forth above, but can be anysuitable size or shape, or can be positioned at any suitable location onthe endoluminal prosthesis 60, 70, respectively. Additionally, the size,shape, or other aspects of the configuration of the endoluminalprostheses 60, 70 are not limited to the specific embodiments describedor illustrated herein. The endoluminal prostheses 60, 70 can compriseany suitable size, shape, including openings or cutouts (e.g., scallops)formed in the proximal and/or distal ends thereof or other aspects ofother suitable configurations known or later developed in the fieldincluding, but not limited to, other known expandable non-bifurcated andbifurcated prostheses. For example, without limitation, in someembodiments, the main body 62, 72 of the prostheses 60, 70,respectively, can comprise any of the materials, features, or otheraspects of the embodiments of the endoluminal vascular prosthesesdisclosed in U.S. Pat. Nos. 6,077,296, 6,187,036, 6,197,049, 6,500,202,6,660,030 and/or 6,733,523, the entirety of which are herebyincorporated by reference as if fully set forth herein.

Without limitation, in some embodiments, the main body 62, 72 of theendoluminal prostheses 60, 70 may comprise any of the materials, shapes,or other aspects of the polymeric sleeves and/or the tubular wiresupports disclosed in U.S. Pat. Nos. 6,077,296, 6,187,036, 6,197,049,6,500,202, 6,660,030 and/or 6,733,523. However, the specific design andselection of the materials, shapes, or other aspects for each of themain bodies 62, 72 of the endoluminal prostheses 60, 70 are not limitedto those set forth in patents set forth above, but can be based on anysuitable variety of materials, shapes, or other aspects of any othersuitable endoluminal prosthesis. In addition, the techniques andconstructions of U.S. Pat. Nos. 6,187,036, 6,197,049, 6,500,202,6,660,030 and/or 6,733,523, the entire contents of which are herebyincorporated by reference herein, can also be used and/or adapted foruse with the main body 62, 72.

With reference to FIGS. 12-19, the deployment of the fenestratedendoluminal prosthesis system described above will be described ingreater detail. FIG. 12 is a partial section view of the endoluminalprosthesis 60 illustrated in FIGS. 10A, 10B positioned within anembodiment of a delivery catheter 78. FIG. 13 is a side view of theembodiment of the endoluminal prosthesis 60 illustrated in FIGS. 10A,10B before the endoluminal prosthesis 60 is placed in a deliverycatheter 78. With reference to FIGS. 12, 13, the hollow guidewires 80,82 can be placed through the openings 64, 66, respectively, of theendoluminal prosthesis 60. In some embodiments, the guidewires 80, 82can be made from a plastic extrusion or metal braids. For example, insome embodiments, the hollow guidewires 80, 82 can be made from braidedNitinol wire. In some embodiments, the outer diameter of the guidewires80, 82 can be approximately 0.035 in and the lumen of the guidewire canbe approximately 0.016 in to accommodate a second 0.014 in guidewire. Insome embodiments, the guidewires 80, 82 can be configured to pass over a0.018 in or any other suitable guidewire. FIG. 14 is a partial sectionview of a patient's vasculature illustrating guidewires 90, 92 insertedthrough the abdominal aortic 94 and into the renal arteries 96, 98,respectively.

In some embodiments the guidewires 80, 82 can support balloons on thedistal end of the guidewires 80, 82. The balloons can be inflated in thebranch vessel to removably anchor or support the guidewire 80, 82against the vessel wall and prevent inadvertent removal of theguidewires from the branch vessels during the deployment procedure. Insome embodiments, for example, one or more occlusion balloon catheterscan be used. Other anchoring mechanisms can be attached to theguidewire, such as, without limitation, hooks, to removably secure oneor more of the guidewires 80, 82 within or to the vessel.

Additionally, in some embodiments, one of more of the guidewiresdisclosed herein (such as, without limitation, guidewires 80, 82) canhave a coiled distal end portion. The coiled distal end portion can beconfigured to be insertable into a branch vessel and can be biased toremain in the branch vessel. In particular, in some embodiments, thesize or diameter of the coils can be greater than the inside diameter ofthe branch vessel so as to bias the coiled portion to remain within thebranch vessel when the proximal end of the guidewire is retracted. Inthis configuration, proximal reaction of the guidewire can cause aproximal end of the coil to unravel, allowing a portion of the coiledportion of the guidewire to be unraveled and retracted while theremaining portion of the coiled portion can remain within the branchvessel. This configuration can inhibit the distal end portion of theguidewire from being inadvertently removed from the branch vessel. Tocompletely remove the coiled distal end portion from the branch vessel,the guidewire can be retracted until the entire coiled portion isunraveled and retracted.

In some embodiments, the length of the coiled portion can beapproximately 6 cm. In some embodiments, the length of the coiledportion can be between approximately 3 cm or less and approximately 5cm, or between approximately 5 cm and approximately 7 cm, or betweenapproximately 7 cm and approximately 9 cm or more, or from or to anyvalues in these ranges. In some embodiments, the unraveled length of thecoiled portion can be approximately 20 cm. In some embodiments, theunraveled length of the coiled portion can be between approximately 10cm or less and approximately 15 cm, or between approximately 15 cm andapproximately 20 cm, or between approximately 20 cm and approximately 25cm or more, or from or to any values in these ranges.

However, the guidewires 80, 82 or any other guidewires disclosed hereincan have any desired or suitable configuration. For example, theguidewires 80, 82 or nay other guidewires disclosed herein can have thesame or similar materials, configurations, methods of fabrication, andother aspects or details as the hollow guidewires set forth in U.S.Patent Application Publication No. US 2004-0098087 A1, titled DUAL WIREPLACEMENT CATHETER (Application Ser. No 10/706,660) filed on Nov. 12,2003, and U.S. application Ser. No. 11/623,022 titled DUAL CONCENTRICGUIDEWIRE AND METHODS OF BIFURCATED GRAFT DEPLOYMENT, filed on Jan. 12,2007, the entirety of both of which are incorporated by reference hereinas if fully set forth herein.

With reference to FIG. 12, the collapsed endoluminal prosthesis 60 canbe supported within the outer sheath 84 of the delivery catheter 78 inthe space between the catheter shaft 86 and the catheter tip 88. In someembodiments, the hollow guidewires 80, 82 can slide through openings orlumens in the catheter shaft 86. Alternatively, in some embodiments, thehollow guidewires 80, 82 can be fixed to the catheter shaft 86.

The hollow guidewires 80, 82 can pass through the outer sheath 84 fromthe proximal end of the delivery catheter 78 to the distal end of thedelivery catheter 78. Each of the hollow guidewires 80, 82 can beconfigured to receive or allow the insertion of 0.014 in guidewiretherethrough. In this configuration, the hollow guidewires 80, 82 canpass over guidewires 90, 92 that can be pre-placed in the approximatelyvasculature.

In this configuration, the endoluminal prosthesis 60 can be retained inthe delivery catheter 78 by the outer sheath 84. As will be described ingreater detail, retraction of the outer sheath 84 can deploy theendoluminal prosthesis 60. With the outer sheath 84 retracted, theendoluminal prosthesis 60 can expand either by self-expansion, balloonexpansion, or by any other suitable method or mechanism. FIG. 15 is aperspective view of the embodiment of the endoluminal prosthesis 60illustrated in FIGS. 10A, 10B in the deployed or expanded state (i.e.,after the outer sheath 84 of the catheter 78 has been retracted and ofthe endoluminal prosthesis 60 has been expanded). FIG. 15 also shows theguidewires 80, 82 passing through the openings 64, 66 respectively. Ascan be seen in FIG. 15, in some embodiments, the catheter 78 can havethree lumens through at least a portion of the catheter 78, each of thethree lumens configured to receive a guidewire. Having three lumensthrough at least a portion of the catheter 78 can prevent twisting ofthe guidewires, so as to ensure proper deployment.

As again illustrated in FIG. 15, each of the 0.014 in guidewires 90, 92can be passed through the hollow guidewires 80, 82, respectively.Therefore, before placing the endoluminal prosthesis 60 across the renalarteries, the guidewires 90, 92 can be maneuvered into the targetvessels, as shown in FIG. 14, which is a partial section view of apatient's vasculature illustrating guidewires 90, 92 inserted throughthe abdominal wall 94 and into the renal arteries 96, 98, respectively.

As illustrated in FIG. 14, third guidewire 100 can be positioned in theaorta 94 at the same time that the 0.014 in guidewires 90, 92 can beplaced in the left and the right renal arteries 96, 98, respectively.The delivery catheter 78 can then be passed over guidewire 100 into theaorta. The hollow guidewires 80, 92 of the delivery system can trackover the guidewires 90, 92 into the renal arteries until the endoluminalprosthesis 60 is positioned in the desired location.

FIG. 16 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis 60 deployed in the desiredposition within the patient's vasculature, after the components of thedelivery catheter 78 except for the guidewires 80, 82 have beenretracted from the patient's vasculature. As has been described, thehollow guidewire 80 can pass over the guidewire 90 through the opening64 into the right renal artery 98. The hollow guidewire 82 can pass overthe guidewire 92 through the opening 66 into the left renal artery 96.

In some embodiments, sutures or makers made from an RO material can besewn into or attached to the endoluminal prosthesis 60 or any otherprosthesis disclosed herein adjacent to the openings formed therein orat any other suitable location to assist the medical practitioner invisualizing the location of the prosthesis relative to the patient'svasculature. For example, without limitation, RO sutures can be sewninto the main body 62 of the endoluminal prosthesis 60 around each ofthe openings 64, 66 and/or near the end portion or portions of the mainbody 62. Alternatively, RO markers can be sewn to or otherwise attachedto the main body of the endoluminal prosthesis 60 or any endoluminalprosthesis at any suitable position.

FIG. 17 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis 60 illustrated in FIGS. 10A, 10Bdeployed in the desired position within the patient's vasculature, afterall of the components of the delivery catheter 78 have been retractedfrom the patient's vasculature, including the hollow guidewires 80, 82.The guidewires 90, 92 can remain in position in the renal arteries. Asillustrated in FIG. 17, the first, smaller opening 64 of the adnominalprosthesis 60 can be approximately aligned with the right renal artery98. As mentioned, the first opening 64 can approximately match the sizeof the opening into the right renal artery 98. Additionally, inreference to FIG. 17, the second, larger opening 66 of the endoluminalprosthesis 60 can be positioned so that the main body 62 of theendoluminal prosthesis 60 does not cover or inhibit the flow of bloodfrom the aortic artery 94 into the left renal artery 96.

FIG. 18 is a partial section view of a patient's vasculatureillustrating the endoluminal prosthesis 70 illustrated in FIGS. 11A, 11Balso deployed in the desired position within the patient's vasculature,after the components of the delivery system except for the guidewireshave been retracted from the patient's vasculature. In FIG. 18, a secondendoluminal prosthesis 70 has been positioned in the desired location ina similar fashion as has been described above with respect to the firstendoluminal prosthesis 60. Again the hollow guidewires 102, 104 of thesecond delivery system can pass over the guidewires 90, 92,respectively. The opening 74 (which, again, can be relatively small ascompared to opening 76) in the second endoluminal prosthesis 70 can beplaced adjacent to the left renal artery 96. The opening 76 (which canbe relatively large as compared to the first opening 74) in the secondendoluminal prosthesis 70 can be placed adjacent to the right renalartery 98.

FIG. 19 is a partial section view of a patient's vasculature illustratedboth endoluminal prostheses 60, 70 positioned in the desired positionwithin the patient's vasculature, after the components of the deliverysystem or systems have been retracted form the patient's vasculature.The small openings 64, 74 of the respective endoluminal prostheses 60,70 provide fenestration to both renal arteries 98, 96, respectively. Theoverlapping endoluminal prostheses 60, 70 ensure a seal of the graftagainst the aorta. Thereafter, an expandable stent can be positioned andexpanded within the endoluminal prostheses 60, 70, in a manner that issimilar to the expandable stents described above, or in any suitablemanner. While the prostheses 60, 70 are described as beingself-expandable, in modified embodiments, one or both of the prostheses60, 70 can be partially or wholly balloon expandable, or expandable byany other means.

FIG. 20 is a perspective view of another embodiment of a fenestratedgraft or endoluminal prosthesis 110 with a scalloped end portion. Withreference to FIG. 20, the endoluminal prosthesis 110 can have a mainbody 112, a first, smaller opening 114, a second, larger opening 116,and one or more cutouts 118 (two being shown) formed at any desiredlocation in an end portion of the main body 112 or at any location inthe main body 112. In some embodiments, with the exception of thedifferences discussed herein and/or illustrated in FIG. 20, otheraspects of the endoluminal prosthesis 110 can be the same as or similarto any of the other endoluminal prostheses disclosed herein, includingbut not limited to the endoluminal prostheses 10, 60 disclosed herein.Furthermore, the endoluminal prosthesis 110 can be deployed and securedin the descried vascular location by any of the same methods asdescribed above with respect to any other endoluminal prostheses,including but not limited to the endoluminal prostheses 10, 60. The oneor more cutouts 118 can be sized and positioned so that the main body112 of the endoluminal prosthesis 110 does not significantly obstructthe flow into any other branch arteries.

For example, the cutouts 117 can be advantageous when positioning theendoluminal prosthesis 110 in the vasculature below the SMA. Any of theendoluminal prostheses or other grafts disclosed in this application orincorporated by reference herein can be formed so as to comprise the oneor more cutouts 118 illustrated in FIG. 20. Again, in some embodiments,sutures or markers made from an RO material can be sewn into or attachedto the endoluminal prosthesis 110 or nay other prosthesis disclosedherein adjacent to one or more of the cutouts 118, one or more theopenings 114, 116 formed therein, near either of the end portions of themain body 112, or at any other suitable location.

FIG. 21 is a perspective view of another embodiment of an endoluminalprosthesis 120. In some embodiments, certain aspects of the endoluminalprosthesis 120 can be the same as or similar to any of the otherendoluminal prostheses disclosed herein, including but not limited tothe endoluminal prostheses 10, 60, 110 disclosed herein. Similar to theprosthesis 10 illustrated in FIG. 1A, the endoluminal prosthesis 120 canhave a main body 122 and a branch graft 124. Additionally, similar tothe prosthesis 60 disclosed herein, the endoluminal prosthesis 120 canhave a larger opening 126 formed in the main body 122 at any desiredaxial or radial position. In some embodiments, the larger opening 126can be positioned on the main body 122 at a radial position that opposesthe branch graft 124 such that the axial centerline of the largeropening 126 is approximately parallel to the axial centerline of thebranch graft 124.

In some embodiments, the branch graft 124 can be integrally formed withor can be sutured, adhered, or otherwise attached to the main body 122in place of the first, smaller opening 64 described above with referenceto endoluminal prosthesis 60. Accordingly, in some embodiments, theendoluminal prosthesis 120 can be deployed in the same manner as orsimilar to the method described above for deploying the endoluminalprosthesis 60. Alternatively, the endoluminal prosthesis 120 can bedeployed by any suitable method. Similar to the embodiment of theendoluminal prosthesis 110 illustrated in FIG. 20, the endoluminalprosthesis 21 can also have one or more cutouts 118 (not shown) formedat any desired location in an end portion of the main body 122. Further,as with any other endoluminal prosthesis disclosed herein, in someembodiments, sutures or makers made from an RO material can be sewn intoor attached to the endoluminal prosthesis 120 adjacent to one or more ofthe cutouts 118 (not illustrated), adjacent to the opening 126 formed inthe main body 122, adjacent to or on the branch graft 124, near eitherof the end portions of the main body 122, and/or at any other suitablelocation.

With reference to FIGS. 22-27, a method of deploying the endoluminalprosthesis 120 will now be described. FIG. 22 is a partial section viewof a patient's vasculature after a first and second endoluminalprosthesis 120, 130 have been positioned within the patient'svasculature, after the components of the delivery system except for thehollow guidewires 80, 82 have been retracted from the patient'svasculature. In some embodiments, as illustrated in FIG. 22, the secondendoluminal prosthesis 130 can be the same as the first endoluminalprosthesis 120 described abode. Further, with reference to FIG. 22, thebranch graft 124 of the first endoluminal prosthesis 120 can bepositioned in the right renal artery 98, while the branch graft 134 ofthe second endoluminal prosthesis 130 can be positioned within the leftrenal artery 96.

Similar to the fenestrated endoluminal prostheses described above, eachendoluminal prosthesis 120, 130 is independently positionable so as toaccommodate a wide range of vasculature geometries or renal arterieswithout requiring a medical practitioner to custom make the endoluminalprosthesis. In some embodiments, the branch graft 124, 134 in theendoluminal prostheses 120, 130 can be sized to match the renal arteryor branch vessel that the branch graft 124, 134 is intended to beinserted into. The position and size of the second larger opening can beconfigured such that it accommodates a wide range of branch vesselconfigurations.

Similar to the deployment of the endoluminal prostheses 60, 70 describedabove, the guidewires 90, 92 can be used for positioning each of theendoluminal prostheses 120, 130, and for guiding the delivery catheterfor each of the branch stents, as will be described below. FIGS. 23 and24 are partial section views of a patient's vasculature illustrating theendoluminal prosthesis 120, 130 deployed in the desired position withinthe patient'vasculature, further illustrating a branch graft deploymentcatheter 140 being guided into the right rental artery 98 over theguidewire 90. With reference to FIGS. 23 and 24, after the first andsecond endoluminal prostheses 120, 130 have been positioned in thedesired location in the patient's vasculature, the branch graftdeployment catheter 140 can be guided up the guide wire 90 into theright renal artery 98. Optionally, if the branch graft deploymentcatheter has a balloon supported by the distal end thereof, the ballooncan be inflated to secure the branch graft deployment catheter withinthe renal artery, as discussed above. Additionally, in some embodiments,coils or hooks supported by the distal end of the branch graftdeployment catheter can be used to secure the branch graft deploymentcatheter within the renal artery.

Once the deployment catheter 140 has reached the desired position suchthat the catheter tip 142 has extended past the end of the branch graft124, as illustrated in FIG. 24, the outer sheath 144 of the deploymentcatheter 140 can be retracted to deploy the stent 146 supported withinthe deployment catheter 140, as illustrated in FIG. 25. The stent 146illustrated in FIG. 24 is a self expanding stent. However, theprocedures disclosed herein can easily be modified by accommodate aballoon expandable or other stent suitable for such use.

As mentioned above, FIG. 25 is a partial section view of a patient'svasculature illustrating an embodiment of a stent 146 being deployed inthe branch graft 124 positioned in a patient's right renal artery 98 byproximally retracting the outer sheath 144 of the deployment catheter140. FIG. 26 illustrates the patient's vasculature after the stent 142has been completely deployed in the branch graft 124 positioned in apatient's right renal artery 98. As illustrated therein, the expansionof the stent 146 can cause the branch graft 124 to expand against theblood vessel 98, so as to secure the graft 124 in the desired position.Note that, in some embodiments, the proximal portion of the branch graft124 (i.e. a portion of the branch graft 124 closest to the main body 122of the endoluminal prosthesis 120, as illustrated in FIG. 25) can bepre-expanded to more approximately match the patient's vasculature inthe pre-deployed state, as was described above with reference toendoluminal prosthesis 10.

Finally, FIG. 27 is a partial section view of a patient's vasculatureillustrating an embodiment of a stent 142 after it has been completelydeployed in the branch graft 124 positioned in a patient's right renalartery 98, further illustrating the delivery catheter 140 being removedfrom the patient's vasculature. Following the procedures described in inconnection with FIGS. 22-27, a stent similar to the stent 146 describedabove can be deployed in the branch graft 134 of the second endoluminalprosthesis 130, so that the branch graft 134 in the left renal artery 96can be supported in the desired position.

Alternatively, the branch grafts 124, 134 can be expanded within therenal artery in a manner similar to any of the methods disclosed hereinfor expanding the branch graft 14 in the blood vessel or renal artery.Alternatively, the branch grafts 124, 134 can be expanded within theblood vessel or renal artery following any other suitable method, whichcan include deploying a self-expanding or balloon expandable bare metalstent or graft covered stent therein after the branch grafts 124, 134have been positioned in the desired blood vessel or renal artery.

Additionally, any of the endoluminal prostheses described herein can beused independently or can be used in conjunction one or more additionalgrafts, including the grafts disclosed herein or any other suitablegrafts such as other tubular or bifurcated grafts. For example, withoutlimitation, any of the endoluminal prostheses disclosed herein orincorporated herein by reference, or either or both of the endoluminalprostheses 120, 130 can be used in conjunction with an additionalprosthesis configured the same or similar to the endoluminal prosthesis120 to accommodate additional branch vessels, and/or any other suitableprostheses, such as without limitation a bifurcated prosthesis.

Additionally, without limitation, any of the endoluminal prosthesesdisclosed herein or incorporated herein by reference, or either or bothof the endoluminal prostheses 120, 130 can be used with any bifurcatedgraft positioned in a patient's vasculature to protect a patient's AAA.In this application, one or more of the endoluminal prostheses disclosedherein (including but not limited to endoluminal prostheses 10, 30, 40,50, 60, 70, 110, and/or 120) can be deployed within the patient'svasculature after the bifurcated graft has been deployed across thepatient's AAA. In this manner, the endoluminal prostheses disclosedherein will be positioned within the bifurcated graft it has beendeployed across the patient's AAA so as to minimize or prevent bloodfrom flowing between the main tubular portion of the bifurcated graftand the patient's blood vessel.

One of ordinary skill in the art will recognize many configurations ofthe fenestrated grafts described herein for the treatment of a mainvessel having two or more branch vessels. As described herein, in someembodiments, the overlap of two or more portions of the endoluminalprostheses each having at least one small and one large opening cancombine to create an endoluminal prosthesis system with two or moresmall openings, which can be used address a wide range of vasculaturegeometries without requiring any custom fabrication of the prostheses.

While the above detailed description has shown, described, and pointedout novel features as applied to various embodiments, it will beunderstood that various omissions, substitutions, and changes in theform and details of the device or process illustrated can be madewithout departing from the spirit of the disclosure. Additionally, thevarious features and processes described above can be used independentlyof one another, or can be combined in various ways. All possiblecombinations and subcombinations are intended to fall within the scopeof this disclosure.

As will be recognized, certain embodiments described herein can beembodied within a form that does not provide all of the features andbenefits set forth herein, as some features can be used or practicedseparately from others. The scope of the inventions is indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

For example, while some embodiments of the delivery and graft systemsare described herein with respect to the abdominal aortic artery, thedelivery and graft systems can be used for repairing vasculature inother portions of the body, including but not limited to the SMA, theinferior mesenteric artery, or any other arteries or blood vessels inthe body suitable for such procedures or apparatuses.

1.-38. (canceled)
 39. A method of delivering an endoluminal prosthesissystem, the method comprising: deploying a first endoluminal prosthesisin a main vessel, the first endoluminal prosthesis comprising a mainbody graft, a first end, a second end, a single lumen extending from thefirst end to the second end, a first lateral opening in a wall portionof the main body graft, and a second lateral opening in the wall portionof the main body graft; positioning a first hollow tubular member thatpasses over a first guidewire and supports a balloon on a distal end ofthe first hollow tubular member through the first lateral opening into afirst branch vessel prior to deploying a distal end of the firstendoluminal prosthesis; and positioning a second hollow tubular memberthat passes over a second guidewire and supports a balloon on a distalend of the first hollow tubular member through the second lateralopening into a second branch vessel prior to deploying a distal end ofthe first endoluminal prosthesis.
 40. The method of claim 39, furthercomprising the steps of inflating the balloon on the distal end of thefirst hollow tubular member, and inflating the balloon on the distal endof the second hollow tubular member.
 41. The method of claim 40, whereinthe first lateral opening is diametrically opposite the second lateralopening.
 42. The method of claim 40, further comprising deploying asecond endoluminal prosthesis in the main vessel, the second endoluminalprosthesis comprising a main body graft, a portion of the main bodygraft of the second endoluminal prosthesis being deployed inside of thefirst endoluminal prosthesis, another portion of the main body graft ofthe second endoluminal prosthesis extending out of the first endoluminalprosthesis; deploying a first stent in the first branch vessel; anddeploying a second stent in the second branch vessel.
 43. The method ofclaim 42, further comprising delivering a first branch graft in thefirst branch vessel prior to deploying the first stent.
 44. The methodof claim 43, further comprising delivering a second branch graft in thesecond branch vessel prior to deploying the second stent.
 45. The methodof claim 42, wherein the first branch graft is connected to the mainbody of the first endoluminal prosthesis.
 46. The method of claim 41,wherein deploying the first stent comprises expanding the first stentwith a balloon that extends into the first branch vessel.
 47. The methodof claim 41, wherein the second endoluminal prosthesis comprises abifurcated graft.
 48. The method of claim 40, wherein the first branchvessel is the left renal artery and the second branch vessel is theright renal artery.